“This judgment is a huge step in the right direction for mutual recognition,” said Patrick Coppens, secretary general of EBF. “It confirms once again the very specific criteria that Member States must respect when making the distinction between food use and medicinal use of herbs.
“It confirms the principles of the regulatory model that EBF experts published last year. It will mean a substantial support for companies that are confronted with similar practices in other Member States.”
The Court of Justice’s final decision held that substances which, while having an effect on the body, do not significantly affect the metabolism or change the way in which the body functions should not be classified as medicinal products by function.
The Judgment stated: “The mere fact that one or more medicinal herbs are among the constituents of a product is not sufficient to permit the conclusion that that product contributes to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.”
The judgment was handed down on Thursday March 5, and came in response to Spain’s practice of systematically considering products that contain herbs as medicinal, despite these products being lawfully manufactured in other Member States as food supplements.
Spain’s practice was seen as incompatible with the principle of the free movement of goods.
“Beneficial effects for health in general, such as those of botanical food supplements, are not sufficient to classify food supplements as medicinal products,” said Manfred Ruthsatz, chairman of the EBF.